TNBC, Triple Negative Breast CancerPhase 2NCT07601178
QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer
A Phase 2 study testing TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ） in people with TNBC, Triple Negative Breast Cancer, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TNBC, Triple Negative Breast Cancer
- What is being tested?
- TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2026to 15 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.
- Female patients aged between 18 and 75 years.
- Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type triple-negative, specifically: ER negative (IHC <1%), PR negative (IHC <1%), HER2 negative (IHC -/+ or IHC ++ but FISH/CISH negative). Priority is given to pathology from metastatic lesions; if metastatic lesion pathology is not available, primary lesion pathology may be used.
- TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent/metastatic disease who are not suitable for surgery, and have not received prior systemic therapy for advanced disease. Prior neoadjuvant and/or adjuvant therapy with taxanes or other anti-tumor treatments is permitted, provided that there was no disease progression during neoadjuvant therapy, and the interval between completion of taxane-based (neo)adjuvant therapy and recurrence/metastasis is ≥6 months.
- Suitable for nab-paclitaxel treatment.
- At least one measurable tumor lesion according to RECIST 1.1 criteria.
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- Expected survival ≥3 months.
- ECOG performance status 0 or 1.
- Adequate organ function, including:
- 1)Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L; hemoglobin (HB) ≥90 g/L.
- 2)Liver function: Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN; if liver metastases are present, ALT and AST must be ≤5×ULN.
- 3)Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60 mL/min (calculated by the Cockcroft-Gault formula).
- 10.Participants of childbearing potential must use appropriate contraception during the study and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must not be lactating.
Who cannot join
- Known history of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or any of their excipients.
- Inability to swallow oral medications, or any gastrointestinal disorder that may interfere with the absorption and metabolism of the study drugs.
- Symptomatic brain/leptomeningeal metastases and/or spinal cord metastases.
- Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes mellitus requiring only stable-dose insulin replacement therapy.
- Major surgery within 3 weeks before study initiation, or failure to recover from surgery.
- History of organ transplantation or autologous/allogeneic stem cell transplantation.
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- Known or self-reported human immunodeficiency virus (HIV) infection.
- HBV-DNA positive or HCV-DNA positive (copy number >10³).
- Prior treatment with any agent targeting the mechanism of tumor immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or immune cell therapy.
- Prior treatment with anti-angiogenic targeted therapy.
- Hypertension that cannot be well controlled with a single antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).
- Arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months before enrollment.
- Presence of other malignancies within 5 years before enrollment, except for TNBC.
- Tumor invasion or compression of surrounding major blood vessels or organs.
- Active central nervous system (CNS) metastatic lesions.
- Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- History of myocarditis, cardiomyopathy, or malignant arrhythmias.
- History of significant bleeding tendency or coagulation dysfunction.
- History of esophageal-gastric varices, severe ulcer, non-healing wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose.
- Known active tuberculosis (TB).
- History of or current non-infectious pneumonitis/interstitial lung disease requiring systemic corticosteroid therapy.
- Major surgery or severe trauma within 30 days before the first dose, or planned major surgery within 30 days after the first dose; minor local surgery within 3 days before the first dose.
- Platelet or red blood cell transfusion within 4 weeks before initiation of study drug treatment.
- Receipt of live vaccine within 4 weeks before the first dose, or planned receipt of live vaccine during the study.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Patients judged by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Lili Zhang, +86 13951004558, lilizhang208ky@163.com
Lili Zhang
About this study
This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer.
A total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study:
Read more
Enrolled participants receive QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression, intolerable toxicity, the investigator's judgment that the participant no longer derives benefit, withdrawal of informed consent by the participant, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.
The study consists of a screening period (from the signing of informed consent to no more than 28 days before the first dose), a treatment period (including on-treatment visits and end-of-treatment visit), and a follow-up period (including safety follow-up and survival follow-up).
Screening Period:
The screening period begins after the participant signs the informed consent form and ends at enrollment, lasting no more than 28 days. Eligible participants are those with pathologically confirmed, previously untreated first-line triple-negative breast cancer. During screening, participant information, samples, and blood specimens are collected as needed. Participants who meet all inclusion criteria and none of the exclusion criteria are enrolled.
Treatment Period:
Study drugs are administered within 3 days of enrollment. Each treatment cycle is 3 weeks. Study treatment continues until disease progression, intolerable toxicity, initiation of new anti-cancer therapy, loss to follow-up, death, withdrawal of informed consent, or other reasons, with a maximum treatment duration of 2 years (whichever occurs first). Safety assessments are performed every 3 weeks, and tumor imaging evaluations are performed every 6 weeks (±7 days) according to RECIST v1.1 criteria.
Follow-up Period:
When participants discontinue study treatment or withdraw early, they are still required to complete the corresponding assessments as specified in the protocol.
Safety Follow-up: At 30 days (±7 days) after the last dose, participants return to the site for one follow-up visit, during which blood samples are collected and safety examinations are performed.
Survival Follow-up: Every 2 months. Survival status and subsequent treatment information are collected by telephone or other appropriate means.
- Conditions
- TNBC, Triple Negative Breast Cancer
- Being tested
- TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）Drug
QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ） | Experimental | QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle Receives: Drug: TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ） |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (1)
ORR
Measured: From enrollment to tumor response，through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start17 Apr 2026
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC, Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lili Zhang, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601178
- Sponsor's protocol ID
- QUEEN-APPLE
- Status last verified
- May 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07601178
- Acronym / sponsor ID
- QUEEN-APPLE
- Conditions
- TNBC, Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer.
A total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study:
Enrolled participants receive QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression, intolerable toxicity, the investigator's judgment that the participant no longer derives benefit, withdrawal of informed consent by the participant, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.
The study consists of a screening period (from the signing of informed consent to no more than 28 days before the first dose), a treatment period (including on-treatment visits and end-of-treatment visit), and a follow-up period (including safety follow-up and survival follow-up).
Screening Period:
The screening period begins after the participant signs the informed consent form and ends at enrollment, lasting no more than 28 days. Eligible participants are those with pathologically confirmed, previously untreated first-line triple-negative breast cancer. During screening, participant information, samples, and blood specimens are collected as needed. Participants who meet all inclusion criteria and none of the exclusion criteria are enrolled.
Treatment Period:
Study drugs are administered within 3 days of enrollment. Each treatment cycle is 3 weeks. Study treatment continues until disease progression, intolerable toxicity, initiation of new anti-cancer therapy, loss to follow-up, death, withdrawal of informed consent, or other reasons, with a maximum treatment duration of 2 years (whichever occurs first). Safety assessments are performed every 3 weeks, and tumor imaging evaluations are performed every 6 weeks (±7 days) according to RECIST v1.1 criteria.
Follow-up Period:
When participants discontinue study treatment or withdraw early, they are still required to complete the corresponding assessments as specified in the protocol.
Safety Follow-up: At 30 days (±7 days) after the last dose, participants return to the site for one follow-up visit, during which blood samples are collected and safety examinations are performed.
Survival Follow-up: Every 2 months. Survival status and subsequent treatment information are collected by telephone or other appropriate means.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ） | Experimental | Drug: TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.
- Female patients aged between 18 and 75 years.
- Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type triple-negative, specifically: ER negative (IHC <1%), PR negative (IHC <1%), HER2 negative (IHC -/+ or IHC ++ but FISH/CISH negative). Priority is given to pathology from metastatic lesions; if metastatic lesion pathology is not available, primary lesion pathology may be used.
- TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent/metastatic disease who are not suitable for surgery, and have not received prior systemic therapy for advanced disease. Prior neoadjuvant and/or adjuvant therapy with taxanes or other anti-tumor treatments is permitted, provided that there was no disease progression during neoadjuvant therapy, and the interval between completion of taxane-based (neo)adjuvant therapy and recurrence/metastasis is ≥6 months.
- Suitable for nab-paclitaxel treatment.
Key exclusion criteria (26 listed)
- Known history of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or any of their excipients.
- Inability to swallow oral medications, or any gastrointestinal disorder that may interfere with the absorption and metabolism of the study drugs.
- Symptomatic brain/leptomeningeal metastases and/or spinal cord metastases.
- Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes mellitus requiring only stable-dose insulin replacement therapy.
- Major surgery within 3 weeks before study initiation, or failure to recover from surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle | Drug | TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ） |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
1 secondary outcome
ORR
Time frame: From enrollment to tumor response，through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ） in people with TNBC, Triple Negative Breast Cancer, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lili Zhang (+86 13951004558, lilizhang208ky@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.